Compliance Specialist II

Compliance Specialist IIJob Location: Northborough, MA (Fully Onsite) Job Duration: 12 Months (possibility of extension) Payrate: $44 - $45/ hr. on w2Main Accountabilities:Ensuring that activities within Product are conducted in compliance with applicable regulatory requirementsEnsuring compliance with Good Manufacturing Practices (GMP) and other relevant regulationsPerform finished product inspections according to standards, specifications established timelinesPerform AQL inspections according to standards, specifications established timelinesTrend AQL failures according to standards, specifications established timelinesEnsuring all batch release activities comply with Good Manufacturing Practices (GMP)Manage the sampling, storing, monitoring and maintenance of finished product retention samples according to standards, specifications and established procedures and timelinesManage / perform annual inspection of retention samplesSupport creation of new material and product specificationsPerform document creation/revision, including periodic reviews, for department documentation according to established procedures and scheduled timelinesSupport department Quality Management System (Change Control, Deviations, CAPA)Support department documentation archival systemCollaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloorManaging / escalating and resolving quality-related issues in a timely and effective mannerSupport the monitoring and analyzing of quality performance metrics, implementing corrective actions as neededSupport root cause analysis investigations for quality incidents and implementing preventive measuresSupport quality walkthroughs.Participating in internal and external audits and regulatory inspections providing support and documentation, as well as speaking as a subject matter expert in area of focusSupport risk management strategies to mitigate potential quality issuesFostering a culture of quality and continuous improvement across the organizationKey Roles:Request corrections when GMP rules are not respected.Prioritize quality and compliance objectives.Request quality improvement initiatives and strategies.Identify discrepancies and corrective/preventive actions that need to be taken.Escalate to upper management any failure in GMP execution on shopfloor.Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures.Advise on how to present a topic and answer specific questions.Advise on risk management strategies and plans.Advise on initiatives to promote a quality-focused culture.Minimum 3 years of related experience.Minimum Education:Bachelors degree.Must have Skills:Quality Shop floor experience, quality assurance review experience.Experience with inspecting finished goods and product.Previous pharma and biotech experience / GMP (strongly preferred).Nice to have:Change Control, Deviations, CAPA (strongly preferred).SAP, Veeva.